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UltraSight's AI-Powered Cardiac Ultrasound Guidance Gets FDA Nod


Indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) in adults, the AI Guidance software reportedly enables novice ultrasound users to obtain real-time cardiac imaging at the point of care.

The Food and Drug Administration (FDA) has granted 510(k) clearance for UltraSight’s AI Guidance software, which may provide improved access to cardiac monitoring by allowing novice ultrasound users to obtain and receive feedback on cardiac ultrasound imaging.

UltraSight said the adjunctive software employs an underlying artificial intelligence (AI) neural network to facilitate ultrasound probe positioning for optimal quality views of the heart. In a 2022 multicenter study, researchers examined the use of the technology by nine residents and registered nurses for 240 cardiac patients. They found that the AI Guidance software allowed successful assessment of left ventricular function 99.6 percent of the time, right ventricular size 93 percent of the time and the presence of significant pericardial effusion 100 percent of the time.

“Ultrasound is a predominant tool in patient diagnosis but its user-dependent functionality and subjectivity in image quality assessment have been hurdles in providing care for heart patients in multiple care settings,” noted Roberto Lang, M.D., the director of cardiovascular imaging at the University of Chicago. “UltraSight’s real-time AI guidance is a gamechanger for diagnostic efficiency and experience. Now with regulatory clearance, medical professionals and patients alike can benefit from this transformative cardiac imaging solution.”

Indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) in adults, the AI Guidance software is compatible with the Philips Lumify Ultrasound System, according to UltraSight.

(Editor’s note: For related content, see “Emerging AI Advances in Cardiac Imaging,” “Ultromics Gets HCPCS Code for AI-Powered EchoGo Heart Failure Device” and “AI Platform for Ultrasound Detection of Cardiac Amyloidosis Gets FDA Breakthrough Designation.”)

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